跳至主要内容
临床试验/NCT04646941
NCT04646941招募中不适用

Diabetic Complications and Obstructive Sleep Apnea in Type 2 Diabetic Patients: A Longitudinal Study

The First Affiliated Hospital of Xiamen University1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2020年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
330
试验地点
1
主要终点
the new onset and types of tumor in T2DM patients

研究概览

简要总结

To follow up the progress of chronic complications in T2DM patients who had undergone anthropometric measurements, laboratory testing and standard overnight polysomnography monitor from 2013 to 2018.

详细描述

Obstructive sleep apnea (OSA) is a common chronic sleep disorder and a frequent comorbidity in patients with type 2 diabetes. There has been increasing recognition that OSA is highly prevalent in persons with type 2 diabetes. This study is to explore the relationship between OSA and the progress of chronic diabetes-related complications in type 2 diabetes who had undergone anthropometric measurements, laboratory testing and standard overnight polysomnography monitor from 2013 to 2018 in the Department of Endocrinology and Diabetes, The First Affiliated Hospital of Xiamen University, Xiamen, China.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes
  • Age:18-80

排除标准

  • Patients with non type 2 diabetes mellitus
  • Preparation for pregnancy
  • Lactation patients
  • Patients with uncontrolled thyroid disease
  • Patients with severe cardiovascular disease
  • Patients with severe hepatic and renal insufficiency
  • Patients with oral and maxillofacial malformations and upper respiratory tract malformations
  • Patients with pulmonary infection or COPD
  • Patients who are not willing to accept the questionnaire survey
  • Unable to sign informed consent

结局指标

主要结局

the new onset and types of tumor in T2DM patients

时间窗: From January 1, 2013 to December 31, 2020

the new onset and types of tumor in T2DM patients

the progress of diabetic complications

时间窗: From January 1, 2013 to December 31, 2020

Diabetic complications include diabetic microvascular complications, atherosclerotic cardiovascular disease(ASCVD), and Diabetic foot disease. Diabetic microvascular complications include diabetic nephropathy, diabetic retinopathy and diabetic neuropathy. Diabetic macrovascular complications refer to ASCVD, which is defined as coronary heart disease (CHD; acute and silent MI, and unstable angina), ischemic stroke, or peripheral artery disease (PAD).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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